Cognitive Enhancement Intervention for Creating a Healthy L.I.F.E (Lifestyle Interventions for Epilepsy)

Sponsor

Kayela Arrotta (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05954182

Collaborator

(none)

170

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The goal of this clinical trial is to test if cognitive interventions in those with diagnosed epilepsy can help lessen cognitive lapses and improve overall brain health.

Participants will participate in weekly, virtual group sessions led by a neuropsychologist for 12 weeks. After the 12-week mark, participants will be asked to practice what they learned for 9 more months. Participants will be asked to complete online questionnaires at certain times during the study. Researchers will compare this intervention group to another group that did not get the intervention to see if the intervention improves brain health. Participation in each of these groups will be randomly assigned. Participation in the study will last for one year.

Condition or Disease	Intervention/Treatment	Phase
Epilepsy	Behavioral: Cognitive Intervention	N/A

Detailed Description

In this prospective, controlled, randomized study, investigators aim to assess the effectiveness of a cognitive intervention in improving daily function (primary outcome) in those with epilepsy. Investigators will also seek to understand how the cognitive intervention may impact objective and subjective cognitive function, quality of life, self-efficacy, locus of control, and mood (secondary outcomes).

The study team will accomplish these objectives by comparing participants that are randomly assigned to the cognitive intervention arm (12 weekly virtual group sessions led by a neuropsychologist followed by 9 months of "self-study" in addition to their standard care) to participants randomly assigned to the control arm (continuation of their standard care during the 12 months of the study). Investigators will measure the effects of the intervention using cognitive assessments, and health and quality of life questionnaires. Investigators will also collect human biospecimens of enrolled participants to assess the biologic impact of the intervention.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

170 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Cognitive Enhancement Intervention for Creating a Healthy L.I.F.E (Lifestyle Interventions for Epilepsy)

Anticipated Study Start Date :

Jul 1, 2023

Anticipated Primary Completion Date :

Jun 1, 2026

Anticipated Study Completion Date :

Jun 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cognitive Intervention Participants in this group will receive weekly, live, virtual group sessions for 12 weeks	Behavioral: Cognitive Intervention This is a virtual, group cognitive intervention. 12 live, weekly sessions will occur during the first 3 months of the study. Groups will be made up of 5-10 participants and will be led by a neuropsychologist. These sessions will include education on the brain and cognitive function as it relates to epilepsy, as well as compensatory strategies for use in daily life. After the 12 sessions, participants will be asked to continue to practice what they learned for the next nine months until their participation ends.
No Intervention: Control Participants in this group will NOT receive the group sessions

Arm

Intervention/Treatment

Experimental: Cognitive Intervention

Participants in this group will receive weekly, live, virtual group sessions for 12 weeks

Behavioral: Cognitive Intervention

This is a virtual, group cognitive intervention. 12 live, weekly sessions will occur during the first 3 months of the study. Groups will be made up of 5-10 participants and will be led by a neuropsychologist. These sessions will include education on the brain and cognitive function as it relates to epilepsy, as well as compensatory strategies for use in daily life. After the 12 sessions, participants will be asked to continue to practice what they learned for the next nine months until their participation ends.

No Intervention: Control

Participants in this group will NOT receive the group sessions

Outcome Measures

Primary Outcome Measures

Change in Everyday Functioning [3-12 months from the beginning of the intervention]
As assessed by the Instrumental Activities of Daily Living-Compensation (IADL-C) questionnaire - Min/Max: 27-216 (higher score means worse outcome)

Secondary Outcome Measures

Change in Cognitive function [3-12 months]
As assessed by neurocognitive testing and the Memory Assessment Clinics Scale for Epilepsy (MAC-E) questionnaire - Min/Max: 30-150 (higher score means better outcome)
Change in Quality of Life [3-12 months]
As assessed by The Quality of Life in Epilepsy (QOLIE) questionnaire - Min/Max: 0-100 (higher score means better outcome)
Change in Stress [3-12 months]
As assessed by The Perceived Stress Scale (PSS) questionnaire - Min/Max: 0-16 (higher score means worse outcome)
Change in Mood [3-12 months]
As assessed by The Patient Health Questionnaire (PHQ) questionnaire - Min/Max: 0-24 (higher score means worse outcome)
Change in Mood [3-12 months]
As assessed by The Generalized Anxiety Disorder (GAD-7) questionnaire - Min/Max: 0-21 (higher score means worse outcome)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Adults, aged 18-60 years old, with diagnosed epilepsy
Objective cognitive deficits as determined by a cognitive screening measure (Brief Assessment of Cognitive Health [BACH])
Able to independently provide informed consent
Fluent in English
Reading abilities at or above 8th grade level as determined by the Wide Range Achievement Test- 4th Edition (WRAT-4), Reading subtest
Internet access and the ability to participate in online video streaming
No history of epilepsy surgery
Willing and able to participate in cognitive intervention

Exclusion Criteria:

Patients with a history of non-epileptic or psychogenic seizures
Any patient that has engaged in any form of cognitive rehabilitation/intervention within the last 6 months
Patients currently enrolled in another interventional study for epilepsy at the time of enrollment
Anticipated or scheduled epilepsy surgery within 6 months
Pending litigation related to the cause of epilepsy or current application for long term disability
Undergoing intensive medical treatment for serious or life-threatening illness (e.g., chemotherapy, etc.) that, in the opinion of the investigator, would impact study participation
Serious psychiatric condition that, in the opinion of the investigator, would interfere with participation, such as schizophrenia, active psychosis, active mania, and current suicidal ideation
Currently pregnant or less than 6 weeks postpartum
Significant hearing and/or vision loss that, in the opinion of the investigator would preclude them from participating in remote cognitive testing and engaging in the cognitive intervention
Participants who require an LAR or lack capacity to consent for themselves

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Kayela Arrotta

Investigators

Principal Investigator: Kayela Arrotta, PhD, The Cleveland Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Kayela Arrotta, Principal Investigator, The Cleveland Clinic

ClinicalTrials.gov Identifier:

NCT05954182

Other Study ID Numbers:

IRB 22-1005

First Posted:

Jul 20, 2023

Last Update Posted:

Jul 20, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Epilepsy

Study Results

No Results Posted as of Jul 20, 2023